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| Product NDC Code | 78732-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Throat coat sweet orange fennel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LOZENGE | ||||
| Application Number | part341 | ||||
| Labeler Name | Traditional Medicinals, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Active ingredient (per drop) Organic menthol 6 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children 12 years and over: Dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor, up to 5 lozenges per day Children under 12 years of age : ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Organic fennel oil, organic glucose syrup, organic licorice extract, organic marshmallow extract, organic orange oil, pectin, organic rapeseed oil, organic raw cane sugar, water.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily relieves Cough due to minor throat and bronchial irritation occurring with the common cold and inhaled irritants. Occasional minor irritaions, pain, sore mouth, and sore throat.
Purpose
Information about the drug product’s indications for use.Purpose Purposes cough suppressant / oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Throat Coat Sweet Orange Fennel Menthol MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM FENNEL OIL CANOLA OIL CORN SYRUP PECTIN WATER LICORICE RAW SUGAR ORANGE OIL ALTHAEA OFFICINALIS ROOT T
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
TRADITIONAL MEDICINALS ® ORGANIC Throat Coat ® Soothes Sore Throats & Relieves Coughs SWEET ORANGE FENNEL Cough Suppressant Oral Anesthetic 16 MENTHOL COUGH DROPS Manufactured for: Traditional Medicinals 1400 Valley House Dr, Suite 120 Rohnert Park, CA 94928 Product of Switzerland
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use Ask a doctor before use if you have: A persistent or chronic cough such as occurs with smoking, asthma, or emphysema. Cough accopanied by excessive phlegm (mucus)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use Do not use: If you are allergic to any of the ingredients. Manufactured in a facility that also handles coconut oil
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children Keep out of reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Each lozenge contains 15 mg of potassium. Store in a cool, dry place. Do not use if the outer wrap is opened or missing.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions call 1-800-543-4372, 9 a.m. - 5 p.m. PST M-F
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor Stop use and ask a doctor if: Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent heacache. This could be the sign of a sereious condition. Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting. Sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persistst or worsesns.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Sore throat warning : Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, or vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 12 years of age unless directed by physician.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API